> be prepared to manage life-threatening anaphylaxis following administration of the drug |
> observe patients for at least two hours after an injection |
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Patients should be offered and know how to initiate emergency self-treatment for anaphylaxis (Where this is prescribed |
& patients should know how and when to administer an adrenaline/epinephrine autojector (Epipen®) with their first |
prescription. Anaphylaxis was reported in clinical trials at a frequency of approximately one in a thousand patients (0.1%); |
usually these reactions occurred within 2 hours of an injection. However the agency has received new reports of delayed |
anaphylaxis (within 2 to 24 hours or even longer) after treatment. |
Please note that for children under the age of 6 omalizumab has a BLACK traffic light. |
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RED Omalizumab injection 150mg |
Risk of anaphylaxis (up to 24hrs after dose) see advice above
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Mepolizumab - NICE TA671 [update to and replaces NICE TA431] |
Mepolizumab, as an add-on therapy, is recommended as an option for treating severe refractory |
eosinophilic asthma in adults only if: |
> it is used for adults who have agreed to and followed the optimised standard treatment plan and |
> the blood eosinophil count has been recorded as 300 cells/microlite or more and the person has has at least 4 exacerbations |
needing systemic corticosteroids in the previous 12 months, or has had continuous oral corticosteroids of at least the |
equivalent of prednisolone 5mg per day over the previous 6 months or |
> the blood eosinophil count has been recorded as 400 cells per microlitre or more and the person has had at least 3 |
exacerbations needing systemic corticosteroids in the previous 12 months (so they are also eligible for either benralizumab or |
reslizumab). |
> the company provides the drug with the discount agreed in the patient access scheme. |
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If mepolizumab, benralizumab or reslizumab are equally suitable, start treatment with the least expensive option (taking into |
account drug and administration costs) |
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At 12 months of treatment: |
> stop mepolizumab if the asthma has not responded adequately or |
> continue treatment if the asthma has responded adequately and assess response each year. |
For further guidance see NICE TA671 |
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RED Mepolizumab 100mg powder for solution for injection |
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Reslizumab - NICE TA479 |
1. Reslizumab, as an add-on therapy, is recommended as an option for the treatment of severe eosinophilic asthma that is |
inadequately controlled in adults despite maintenance therapy with high-dose inhaled corticosteroids plus another drug, only if: |
> the blood eosinophil count has been recorded as 400 cells per microlitre or more |
> the person has had 3 or more severe asthma exacerbations needing systemic corticosteroids in the past 12 months and |
> the company provides reslizumab with the discount agreed in the patient access scheme. |
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1.2. At 12 months: |
> stop reslizumab if the asthma has not responded adequately or |
> continue reslizumab if the asthma has responded adequately and assess response each year. |
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An adequate response is defined as: |
> a clinically meaningful reduction in the number of severe exacerbations needing systemic corticosteroids or |
> a clinically significant reduction in continuous oral cortiscosteroid use while maintaining or improving asthma control. |
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RED Reslizumab |
100mg/10ml concentration for solution for infusion (Cinqaero®) (NHS England Commissioned) |
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Benralizumab - NICE TA565 - updated September 2019 |
Benralizumab, as and add-on therapy, is recommended as an option for treating severe eosinophilic asthma that is |
inadequately controlled in adults despite maintenance therapy with high-dose inhaled corticosteroids and long-acting beta- |
agonists, only if: |
> and person has agreed to and followed the optimised standard treatment plan and |
> and blood eosinophil count has been recorded as 300 cells per microlitre or more and the person has had 4 or more |
exacerbations needing systemic corticosteroids in the previous 12 months, or has had continuous oral corticosteroids of |
at least the equivalent of prednisolone 5 mg per day over the previous 6 months (that is, the person is eligible for |
mepolizumab) or |
> the blood eosinophil count has been recorded as 400 cells per microlitre or more with 3 or more exacerbations |
needing systemic corticosteroids in the past 12 months (that is, the person is eligible for reslizumab). |
Benralizumab is recommended only if the company provides it according to the commercial arrangement. |
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RED Benralizumab |
30mg/1mL solution for injection pre-filled syringes (Fasenra▼) |
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Tezepelumab - NICE TA880 NHS England Commissioned |
Tezepelumab as an add-on maintenance treatment is recommended as an option for severe asthma in people 12 years and |
when treatment with high-dose inhaled corticosteroids plus another maintenance treatment has not worked well enough. |
It is recommended only if people: |
> have had 3 or more exacerbations in the previous year, or |
> are having maintenance oral corticosteroids/ |
Tezepelumab is recommended only if the company provides it according to the commercial arrangement. |
RED Tezepelumab (Tezspire solution for injection pre-filled syringes 210mg/1.91mL) |
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3.3.3 Phophodiesterase type-4 inhibitors |
NICE guidance TA461 (update to TA244) |
Roflumilast, as an add-on to bronchodilator therapy, is recommended as an option for treating severe chronic obstructive |
pulmonary disease in adults with chronic bronchitis, only if: |
> the disease is severe, defines as a forced expiratory volume in 1 second FEV¹ after a bronchodilator of less than 50% of |
predicted normal, and |
> the person has ja 2 or more exacerbations in the previous 12 months despite triple inhaled therapy with a long-acting |
muscarinic antagonist, a long-acting beta-2 agonist and an inhaled corticosteroid. |
Treatment with roflumilast should be started by a specialist in respiratory medicine. |
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AMBER Roflumilast tablets 500mcg (Daxas®) |
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All material in this section is aimed at health care professionals, but is information currently held in the public domain, members of the | public seeking advice on medicine-related matters are advised to speak with their GP, pharmacist, nurse or contact NHS111 Service | Email: info.elmmb@nhs.net | Copyright© 2016 - 2020 East Lancashire Medicines Management Board | All rights reserved. Disclaimer/Terms and conditions | |
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